Trials / Unknown
UnknownNCT03522649
A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer
A Phase III, Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With FOLFIRI Versus Napabucasin in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 668 (estimated)
- Sponsor
- 1Globe Health Institute LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Napabucasin | Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours. |
| DRUG | Fluorouracil | Fluorouracil 400 mg/m\^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by Fluorouracil 1200 mg/m\^2/day (total 2400 mg/m\^2) continuous infusion. |
| DRUG | Leucovorin | Irinotecan 180 mg/m\^2 followed by or concurrent with leucovorin 400 mg/m\^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively. |
| DRUG | Irinotecan | Irinotecan 180 mg/m\^2 followed by or concurrent with leucovorin 400 mg/m\^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively. |
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2021-11-01
- Completion
- 2021-11-01
- First posted
- 2018-05-11
- Last updated
- 2019-06-18
Locations
37 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03522649. Inclusion in this directory is not an endorsement.